NCT01728948CompletedNot Applicable
Non-interventional Study of Effectiveness of Elderly Metastatic Renal Cell Carcinoma (mRCC) Treated With Sorafenib
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Bayer
- Enrollment
- 60
- Primary Endpoint
- Overall survival
Study Overview
Brief Summary
This prospective, single arm, multi-center pilot study includes 120 mRCC patients over 65 years, no prior systemic treatment, determined to be candidates for systemic therapy by the investigator. The treatment with Sorafenib should comply with the recommendations written in the local product information. The primary endpoint is overall survival. The secondary endpoints including other effectiveness points, safety and patients characteristics. With 120 completed patients, if the observed survival rate at 12 months is 60%, the width of a 95% confidence interval will be approximately 18%.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 65 Years to — (Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients with histologically/cytologically diagnosed metastasis RCC who are candidates for systemic therapy and have decided to accept Sorafenib treatment.
- •>=65 years of age
- •Patients who have signed the informed consent
- •Patients with a life expectancy of ≥12 weeks
- •No prior systemic treatment
Exclusion Criteria
- •The approved local product label must be followed for the exclusion criteria
Arms & Interventions
Group 1
Intervention: Sorafenib (Nexavar, BAY43-9006) (Drug)
Outcomes
Primary Outcomes
Overall survival
Time Frame: up to 2.5 years
Secondary Outcomes
- Progression free survival by the Response Evaluation Criteria in Solid Tumor (RECIST) Criteria(up to 2.5 years)
- Disease control rate by the Response Evaluation Criteria in Solid Tumor (RECIST) Criteria(up to 2.5 years)
- Survival rate by one year(up to 1 year)
- Number of participants with adverse events (AE) and Serious adverse events (SAE) as a measure of safety and tolerability(up to 3.5 years)
- Patient characteristics (birthdate (at least year), sex, weight, height, etc)(up to 2.5 years)
- Response rate (RR)(up to 3.5 years)
- Time to first relief of clinical symptoms and physical signs(up to 3.5 years)
- Treatment pattern(up to 3.5 years)
Investigators
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